Failed ISO Doc to be Reconsidered

12/01/1999

By Kelly Sewell



SAN JOSE, CA—An update of ISO standards presented at CleanRooms West '99 last month revealed that the first document of the Biocontamination Control set (14698) was voted down in July.

"There were reasons it was voted against, but fundamentally, it's sound and worthy of moving forward. Items need to change, but overall, the content is solid," says Anne Marie Dixon, head of the US delegation to ISO/TC 209.

"The basic document, ISO 14698-1, "Biocontamination-general principles," failed the DIS [draft international standard] vote by one vote," says Dixon.

The two supporting documents, 14698-2, "Biocontamination — evaluation and interpretation of biocontamination data," and 14698-3, "Biocontamination — Methodology for measuring the efficiency of process of cleaning and/or disinfection inert surfaces bearing biocontaminated soiling or biofilms," passed in July. However, they cannot move forward until the keystone document has passed. The 14698-1 document was to be reviewed again at the ISO/TC 209 meeting in November, which hadn't yet taken place at press time.

According to Richard Matthews, chairman of ISO/TC 209, which is responsible for writing global cleanroom standards, the dissenting vote was cast because "there was a change in the constitution of delegates, and the people voting this time weren't involved in the development of the initial documents."

"Also, the Europeans, who voted against it were expecting it to be a regulation. However, ISO doesn't make regulations," Matthews continues. "It floundered because of politics. But all that will change in November," Matthews adds.